Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Respiratory Syncytial Virus Infection
In brief
The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants. It is hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to placebo.
Key facts
- Study ID
- NCT04767373
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 3632
- Starts
- 2021-04-07
- Expected to finish
- 2024-07-09
- Last updated by the study team
- 2026-02-11
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: accepted.
Where it is running
- Northwest Arkansas Pediatric Clinic ( Site 0050) — Fayetteville, Arkansas, United States
- Children's Clinic of Jonesboro, PA ( Site 0058) — Jonesboro, Arkansas, United States
- Long Beach Memorial Medical Center ( Site 0014) — Long Beach, California, United States
- Madera Family Medical Group ( Site 0046) — Madera, California, United States
- Orange County Research Institute ( Site 0057) — Ontario, California, United States
- Children's Hospital Colorado ( Site 0066) — Aurora, Colorado, United States
- Optumcare Colorado Springs, LLC ( Site 0022) — Colorado Springs, Colorado, United States
- Children's National Hospital ( Site 0076) — Washington D.C., District of Columbia, United States
- MedStar Georgetown Pediatrics ( Site 0047) — Washington D.C., District of Columbia, United States
- Next Phase Research Alliance, LLC ( Site 0071) — Homestead, Florida, United States
- Acevedo Clinical Research Associates ( Site 0002) — Miami, Florida, United States
- Tekton Research ( Site 0080) — Chamblee, Georgia, United States
- Meridian Clinical Research, LLC ( Site 0083) — Macon, Georgia, United States
- Clinical Research Prime ( Site 0075) — Idaho Falls, Idaho, United States
- Saltzer Medical Group ( Site 0004) — Nampa, Idaho, United States
- Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0061) — Topeka, Kansas, United States
- ACC Pediatric Research ( Site 0067) — Haughton, Louisiana, United States
- Meridian Clinical Research, LLC ( Site 0082) — Hastings, Nebraska, United States
- Midwest Children's Health Research Institute, LLC ( Site 0044) — Lincoln, Nebraska, United States
- Dartmouth-Hitchcock Medical Center ( Site 0031) — Lebanon, New Hampshire, United States
- Rutgers University-Pediatric Clinical Research Center ( Site 0055) — New Brunswick, New Jersey, United States
- Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics ( Site 0093) — Winston-Salem, North Carolina, United States
- Senders Pediatrics ( Site 0062) — Cleveland, Ohio, United States
- Ohio Pediatric Research Association ( Site 0063) — Dayton, Ohio, United States
- Southeastern Pediatric Associates, P.A. ( Site 0008) — Dothan, Alabama, United States
Full record on ClinicalTrials.gov
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